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Pharma Services Category of Dalton Pharma Services

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API Development

Analytical Testing Services

Biologic Drugs

Continuous Flow Process

Custom Synthesis & Manufacturing

Fine Chemical / Intermediate

Injectable / Parenteral

Injectable / Sterile APIs

Lyophilization

Packaging and Distribution Testing

Preformulation & Material Science

Process Development & Optimization

Protein / Peptide

Reference Standard

Separation & Purification

Small Scale Batch

Stability Studies

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Dalton Pharma Services

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CANADA

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Sterile Liquid Injectables

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Dalton is a leader in the sterile cGMP manufacture of aseptically filled or terminally sterilized liquid parenteral vials. Batch sizes range from 100’s of vials up to 15,000 vials per batch.

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Pharma Service: Drug Product Manufacturing

Category: Injectable / Parenteral

Sub Category: Overview

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Lyophilization

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Dalton uses its upgraded sterile filling room to aseptically fill the vials and then transfers them to our fully programmable cGMP lyophilizer. Our lyophilization batch sizes can range from 6936 vials (2 ml vial configuration) to 680 vials

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Pharma Service: API Manufacturing

Category: Lyophilization

Sub Category: Overview

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Sterile Lyophilized Vials

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Dalton offers high quality lyophilization services which include cycle optimization and cGMP production for clinical scale batches.

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Pharma Service: Drug Product Manufacturing

Category: Injectable / Parenteral

Sub Category: Overview

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Sterile Powder Filling in Vials

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Dalton specializes in cGMP sterile powder filling into vials. Our unique capability allows us to fill neat sterile powders with suitable flow characteristics into vials in a Class A (100) environment.

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Pharma Service: Drug Product Manufacturing

Category: Injectable / Parenteral

Sub Category: Overview

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Clinical Sterile Vial Manufacturing

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Dalton offers a selection of in-stock vial container closure options and commonly used excipients to deliver your aseptic clinical materials faster in full compliance.

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Pharma Service: Drug Product Manufacturing

Category: Injectable / Parenteral

Sub Category: Clinical Supply

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cGMP Sterile API Manufacturing

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Dalton offers the manufacturing of sterile cGMP APIs by a variety of methods including sterile filtration and dry heat sterilization. Our sterile product manufacturing capabilities include sterile filling of powders, liquids and lyophilization.

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Pharma Service: API Manufacturing

Category: Injectable / Sterile APIs

Sub Category: Overview

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mg to Multi-Kilogram Scale Batch (up to 300L ...

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Dalton Pharma Services is an ideal contract partner for your API Process Development. We are FDA registered and Health Canada approved, and provide integrated process development, API manufacturing and finished dose manufacturing at a single location.

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Pharma Service: API Manufacturing

Category: Small Scale Batch

Sub Category: Overview

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Continuous Process

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- Service Details

Dalton Pharma Services is an ideal contract partner for your API Process Development. We are FDA registered and Health Canada approved, and provide integrated process development, API manufacturing and finished dose manufacturing at a single location.

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Pharma Service: API Manufacturing

Category: Continuous Flow Process

Sub Category: Overview

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Optimization of Existing Synthetic Routes

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Dalton Pharma Services is an ideal contract partner for your API Process Development. We are FDA registered and Health Canada approved, and provide integrated process development, API manufacturing and finished dose manufacturing at a single location.

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Pharma Service: API Manufacturing

Category: Process Development & Optimization

Sub Category: Overview

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GMP Friendly Alternative Synthetic Routes Dev...

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Dalton Pharma Services is an ideal contract partner for your API Process Development. We are FDA registered and Health Canada approved, and provide integrated process development, API manufacturing and finished dose manufacturing at a single location.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

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IP Protected Synthetic Routes Development

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Dalton Pharma Services is an ideal contract partner for your API Process Development. We are FDA registered and Health Canada approved, and provide integrated process development, API manufacturing and finished dose manufacturing at a single location.

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Pharma Service: API Manufacturing

Category: Custom Synthesis & Manufacturing

Sub Category: Route Scouting

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Process Parameterization & Optimization

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Statistical Design of Experiments (DoE) for process parameterization and optimization

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Pharma Service: API Manufacturing

Category: Process Development & Optimization

Sub Category: Overview

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Dev. & Optimization of Purification & Isolati...

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Dalton Pharma Services is an ideal contract partner for your API Process Development. We are FDA registered and Health Canada approved, and provide integrated process development, API manufacturing and finished dose manufacturing at a single location.

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Pharma Service: API Manufacturing

Category: Separation & Purification

Sub Category: Extraction & Isolation

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Isolation of Active Ingredients from Natural ...

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Dalton Pharma Services is an ideal contract partner for your API Process Development. We are FDA registered and Health Canada approved, and provide integrated process development, API manufacturing and finished dose manufacturing at a single location.

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Pharma Service: API Manufacturing

Category: Separation & Purification

Sub Category: Extraction & Isolation

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Polymorphism Study

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Dalton Pharma Services is an ideal contract partner for your API Process Development. We are FDA registered and Health Canada approved, and provide integrated process development, API manufacturing and finished dose manufacturing at a single location.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Polymorph & Crystal Screening

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Custom Synthesis of Pharmaceutical Impurities

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Dalton’s Custom Synthesis and Fine Chemical services offers a wide range of experience in the synthesis of low volume, high value small molecules for biotechnology and pharmaceutical applications.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Custom Synthesis

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Fine Chemical

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Dalton’s Custom Synthesis and Fine Chemical services offers a wide range of experience in the synthesis of low volume, high value small molecules for biotechnology and pharmaceutical applications.

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Pharma Service: API Manufacturing

Category: Fine Chemical / Intermediate

Sub Category: Overview

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Pharmaceutical Intermediates

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Dalton’s Custom Synthesis and Fine Chemical services offers a wide range of experience in the synthesis of low volume, high value small molecules for biotechnology and pharmaceutical applications.

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Pharma Service: API Manufacturing

Category: Fine Chemical / Intermediate

Sub Category: Overview

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Reference Standards & Certified Reference Mat...

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Dalton’s Custom Synthesis and Fine Chemical services offers a wide range of experience in the synthesis of low volume, high value small molecules for biotechnology and pharmaceutical applications.

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Pharma Service: API Manufacturing

Category: Reference Standard

Sub Category: Overview

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Custom Peptide Synthesis

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Dalton can provide material in a range of peptide purity from 70-98%. Mass spectrometry is used to verify the mass of the peptide.

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Pharma Service: API Manufacturing

Category: Protein / Peptide

Sub Category: Synthesis

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Antibody-Drug Conjugate (ADC)

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Dalton Pharma Services is a recognized leader in offering custom Conjugation Services as a tool for Drug Delivery, Targeted Drug Delivery, Synergistic Drug and Gene Delivery, or Diagnostic applications.

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Pharma Service: Drug Product Manufacturing

Category: Biologic Drugs

Sub Category: Antibody Drug Conjugate

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Polymorphic Screening

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- Service Details

Dalton Pharma Services can perform screening of polymorphic forms for any API of interest via state of the art analysis including DSC, XRPD, FTIR and dissolution/solubility testing to determine the best polymorphic form for your product.

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Pharma Service: API & Drug Product Development

Category: Preformulation & Material Science

Sub Category: Polymorph & Crystal Screening

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Structure Elucidation of Impurities

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- Service Details

With over 2,000 high quality research molecules in our catalogue, Dalton has over 30 years of expertise in structure elucidation of unknown synthetic impurities, intermediates, degradants, and excipient-related impurities.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Structure Elucidation

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Impurity Screening

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Identification of Unknown impurities of >0.05% abundance using internally developed or client supplied method.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Impurity Reference Standards

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- Service Details

Identified compounds can be ultra-purified for use as reference standards for QC analysis and stability impurity monitoring studies.

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Pharma Service: API & Drug Product Development

Category: API Development

Sub Category: Impurity / Reference Standard

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Microbiology

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Dalton offers a full range of microbiology testing services to support every product need.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Microbiology

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Bioburden Analysis

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Dalton offers a full range of microbiology testing services to support every product need.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Microbiology

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Microscopic Procedures

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Dalton offers a full range of microbiology testing services to support every product need.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Light Microscopy

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Water Testing

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Dalton offers a full range of microbiology testing services to support every product need.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Karl Fischer / Water Analysis

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Particulate Matter Testing

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Dalton offers a full range of microbiology testing services to support every product need.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Particulate Matter

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Sterility Testing

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Dalton offers a full range of microbiology testing services to support every product need.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Microbiology

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Accelerated Stability Testing

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Dalton supports its customers' products with our in-house stability services including full stability services from protocol development for accelerated stability, intermediate term stability and long term stability programs.

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Pharma Service: Analytical

Category: Packaging and Distribution Testing

Sub Category: Shelf Life and Accelerated Aging Testing

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Dev. & Evaluation of Stability Indicating Met...

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Dalton supports its customers' products with our in-house stability services including full stability services from protocol development for accelerated stability, intermediate term stability and long term stability programs.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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Long-Term Stability Testing

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Dalton supports its customers' products with our in-house stability services including full stability services from protocol development for accelerated stability, intermediate term stability and long term stability programs.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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Intermediate Stability testing

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Dalton supports its customers' products with our in-house stability services including full stability services from protocol development for accelerated stability, intermediate term stability and long term stability programs.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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Formulation Evaluation Stability Testing

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Dalton supports its customers' products with our in-house stability services including full stability services from protocol development for accelerated stability, intermediate term stability and long term stability programs.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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Forced Degradation Studies

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Dalton supports its customers' products with our in-house stability services including full stability services from protocol development for accelerated stability, intermediate term stability and long term stability programs.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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Controlled Drug Products Stability Testing

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Dalton supports its customers' products with our in-house stability services including full stability services from protocol development for accelerated stability, intermediate term stability and long term stability programs.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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Commercial Product Stability Testing

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Dalton supports its customers' products with our in-house stability services including full stability services from protocol development for accelerated stability, intermediate term stability and long term stability programs.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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Comparator Stability Testing

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Dalton supports its customers' products with our in-house stability services including full stability services from protocol development for accelerated stability, intermediate term stability and long term stability programs.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Overview

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Photostability

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- Service Details

Dalton supports its customers' products with our in-house stability services including full stability services from protocol development for accelerated stability, intermediate term stability and long term stability programs.

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Pharma Service: Analytical

Category: Stability Studies

Sub Category: Photostability

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SEC-MALS

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It is more important than ever to be able to characterize your large molecule product with confidence. Dalton has added GMP/GLP Size Exclusion Chromatography – Multi Angle (Laser) Light Scattering (SEC-MALS) to its analytical services offering.

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Pharma Service: Analytical

Category: Analytical Testing Services

Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)

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ICP-MS Elemental Analysis

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- Service Details

In accordance with the updated ICH Q3D Guideline for Elemental Impurities, Dalton now offers ICP-MS testing services.

Pharma Services Category of Dalton Pharma Services

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